1. Field of the Invention
This invention in general relates to orally administrable pharmaceutical formulations and in particular to a pharmaceutical formulation prepared into a soft gelatin capsule containing Pseudoephedrine hydrochloride as the active ingredient.
2. Description of the Related Art
Pseudoephedrine hydrochloride is a drug that has serious potential for abuse. This is so because Pseudoephedrine or Ephedrine could be extracted from various drug products containing Pseudoephedrine hydrochloride and can be converted into amphetamines. Amphetamines have potentially lethal stimulant effects on the central nervous system and heart and are among the most frequent drugs of abuse. Accordingly, it is important to minimize such abuse potential.
Pseudoephedrine HCl is a vasoconstrictor, which produces vasoconstriction by stimulating (alpha)-receptors within the mucous of the respiratory tract. Clinically Pseudoephedrine shrinks the swollen mucous membranes, reduces tissue hyperemia, edema and nasal congestion, and increases nasal airway patency. Its use is therefore significant in the relief from nasal congestion.
Pseudoephedrine HCl tablets used for the temporary relief of nasal congestion such as is caused by common cold are commercially available in various strengths. However, soft gelatin formulations containing only Pseudoephedrine HCl as an active ingredient are not commercially available. The following table contains details of commercially available soft gelatin formulations comprising Pseudoephedrine HCl or Pseudoephedrine in combination with antihistamines and/or analgesics.
Active Ingredient/s(Each Capsule contains)Brand Name/ManufacturerGuaifenesin 200 mgRobitussin Cold & Cough/Pseudoephedrine HCl 30 mgA. H. RobinsDextromethorphan HBr 10 mgPseudoephedrine HCl 30 mgNyquil/Doxylamine succinate 6.25 mgProctor & GambleDextromethorphan HBr 10 mgAcetaminophen 200 mgPseudoephedrine HCl 30 mgDayquil/Dextromethorphan HBr 10 mgProctor & GambleAcetaminophen 200 mgPsueodephedrine HCl 30 mgAlka-Seltzer PlusDoxylamine succinate 6.25 mgNight-Time Cold MedicineDextromethorphan HBr 10 mgBayerAcetaminophen 325 mgPseudoephedrine HCl 30 mgAlka-Seltzer PlusChlorpheniramine Maleate 2 mgCold & Cough MedicineDextromethorphan HBr 10 mgBayerAcetaminophen 325 mgPseudoephedrine HCl 30 mgAlka-Seltzer PlusChlorpheniramine Maleate 2 mgCold & Cough MedicineAcetaminophen 325 mgBayerPseudoephedrine HCl 30 mgAlka-Seltzer PlusAcetaminophen 325 mgCold & Sinus MedicineBayerPseudoephedrine HCl 30 mgAlka-Seltzer PlusDextromethorphan HBr 10 mgCold & Cough MedicineAcetaminophen 325 mgBayer
U.S. Pat. No. 5,409,907 to Blase et. al describes a pharmaceutical suspension comprising a therapeutic amount of pharmaceutically active agent selected from the group consisting of acetaminophen, famotidine, pseudoephedrine hydrochloride, chlorpheniramine maleate, astemizole, dextromethorphan hydrobromide, guaifenesin, diphenhydramine hydrochloride, loperamide hydrochloride, simethicone, antacids, and combinations thereof. However, the suspending system described therein comprises an effective amount of xanthan gum and microcrystalline cellulose.
A composition including soybean oil, yellow beeswax and lecithin has been disclosed in the U.S. Pat. No. 6,309,667 to Horvath et al. This disclosure does not address Pseudoephedrine HCl as an ingredient in combination with the other excipients.
U.S. Pat. No. 5,175,002 is addressed at a suspension formulation comprising soybean oil, lecithin and wax. However the active in this formulation is Amantidine Hydrochloride.
U.S. Pat. No. 5,112,602 to Beurline et al. discloses an oral pharmaceutical liquid suspension comprised of theophylline as the active agent, silicon dioxide, a wetting agent and a hydrocolloid gum.